Amoxicillin

Product NDC: 0093-2268
11-digit product format: 000932268
Labeler code: 0093
Product ID: 0093-2268_31223839-1653-4906-826a-f9d6af179334
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA064013
Marketing category: ANDA
Marketing start: 1993-01-01
Substance: AMOXICILLIN
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A064013-001	AMOXICILLIN	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL		RS	1992-12-22
A064013-002	AMOXICILLIN	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL			1995-09-11

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064013-001	AMOXICILLIN	250MG	TABLET, CHEWABLE / ORAL	RS	1992-12-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064013-002	AMOXICILLIN	125MG	TABLET, CHEWABLE / ORAL		1995-09-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A064013-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064013-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064013-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064013-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A064013-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064013-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A064013-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064013-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A064013-002	AB	1	`c0c555d07b60…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239191	Internal RxNorm lookup
308177	Internal RxNorm lookup
308182	Internal RxNorm lookup
308189	Internal RxNorm lookup
308191	Internal RxNorm lookup
308192	Internal RxNorm lookup
308194	Internal RxNorm lookup
313850	Internal RxNorm lookup
598025	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4c0f348a-a65d-409c-8668-207c82a5e3cb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-2268-01	Amoxicillin	100 in 1 BOTTLE	TABLET, CHEWABLE	100		37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-2268-01	EA - Each	0093-2268	e84b5533-4c75-40be-856f-c530d84d4cfc	1	2012-07-24
0093-2268-05	EA - Each	0093-2268	3c38602f-ebd3-41b3-bb8e-4b2276193c68	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN CAPSULE AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]	15
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]	5
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.]	3
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE [DIRECT RX]	1
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE [DIRECT RX]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	AMOXICILLIN CAPSULE [DIRECT RX]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMOXICILLIN CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMOXICILLIN CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE [DIRECT RX]	1
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	AMOXICILLIN CAPSULE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE [DIRECT RX]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMOXICILLIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMOXICILLIN CAPSULE [DIRECT RX]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN TABLET, CHEWABLE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-2268	AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION AMOXICILLIN TABLET, CHEWABLE AMOXICILLIN CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	34	Current NDC, Legacy NDC, 1 package rows	20250502_4c0f348a-a65d-409c-8668-207c82a5e3cb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	452eb254-028a-4e02-9cb0-85483a4abaf5	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
AMOXICILLIN	AMOXICILLIN	Chartwell RX, LLC	b07b5ac4-253e-4c83-91c3-3fdc46e91a0f	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	26e257d5-5b98-3795-e063-6394a90a05bc	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	98e9274c-c02e-44d9-8cc5-17536ef03a77	2025-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	PD-Rx Pharmaceuticals, Inc.	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals, Inc.	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Proficient Rx LP	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013
Amoxicillin	AMOXICILLIN	Teva Pharmaceuticals USA, Inc.	4c0f348a-a65d-409c-8668-207c82a5e3cb	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013 ndc (product): 0093-2268
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	63b395ca-f0ea-4429-b8aa-18f495596e4d	2024-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064013 application number: ANDA064013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308177	amoxicillin 125 MG Chewable Tablet	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
598025	amoxicillin 250 MG Chewable Tablet	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308182	amoxicillin 250 MG Oral Capsule	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308191	amoxicillin 500 MG Oral Capsule	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308192	amoxicillin 500 MG Oral Tablet	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308194	amoxicillin 875 MG Oral Tablet	PSN	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308177	amoxicillin 125 MG Chewable Tablet	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
598025	amoxicillin 250 MG Chewable Tablet	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308182	amoxicillin 250 MG Oral Capsule	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308191	amoxicillin 500 MG Oral Capsule	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308192	amoxicillin 500 MG Oral Tablet	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308194	amoxicillin 875 MG Oral Tablet	SCD	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	4c0f348a-a65d-409c-8668-207c82a5e3cb	37
313797	amoxicillin 125 MG in 5 mL Oral Suspension	PSN	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
598025	amoxicillin 250 MG Chewable Tablet	PSN	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
313797	amoxicillin 25 MG/ML Oral Suspension	SCD	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
598025	amoxicillin 250 MG Chewable Tablet	SCD	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
313797	amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension	SY	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
313797	amoxicillin 125 MG per 5 ML Oral Suspension	SY	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	63b395ca-f0ea-4429-b8aa-18f495596e4d	29
598025	amoxicillin 250 MG Chewable Tablet	PSN	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	28
598025	amoxicillin 250 MG Chewable Tablet	SCD	09660a95-a7b3-4d1f-832c-a4fa7a5b7ddd	28
598025	amoxicillin 250 MG Chewable Tablet	PSN	98e9274c-c02e-44d9-8cc5-17536ef03a77	24
598025	amoxicillin 250 MG Chewable Tablet	SCD	98e9274c-c02e-44d9-8cc5-17536ef03a77	24
598025	amoxicillin 250 MG Chewable Tablet	PSN	452eb254-028a-4e02-9cb0-85483a4abaf5	19
598025	amoxicillin 250 MG Chewable Tablet	SCD	452eb254-028a-4e02-9cb0-85483a4abaf5	19
598025	amoxicillin 250 MG Chewable Tablet	PSN	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	6
598025	amoxicillin 250 MG Chewable Tablet	SCD	3d6cf1b3-f1dc-4eab-e054-00144ff88e88	6
598025	amoxicillin 250 MG Chewable Tablet	PSN	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	5
598025	amoxicillin 250 MG Chewable Tablet	SCD	52e676e4-b70e-4e73-bbe7-f54d91ca7e0a	5
598025	amoxicillin 250 MG Chewable Tablet	PSN	e91786c4-f928-4419-bd57-eca11498a6e6	3
598025	amoxicillin 250 MG Chewable Tablet	PSN	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	3
598025	amoxicillin 250 MG Chewable Tablet	SCD	e91786c4-f928-4419-bd57-eca11498a6e6	3
598025	amoxicillin 250 MG Chewable Tablet	SCD	8c3dd74c-872a-1ba1-e053-2a95a90a7cb3	3
598025	amoxicillin 250 MG Chewable Tablet	PSN	26e257d5-5b98-3795-e063-6394a90a05bc	2
308182	amoxicillin 250 MG Oral Capsule	PSN	a3b98df9-eddc-441a-84dd-51bc5f8dc6e4	2
598025	amoxicillin 250 MG Chewable Tablet	SCD	26e257d5-5b98-3795-e063-6394a90a05bc	2
308182	amoxicillin 250 MG Oral Capsule	SCD	a3b98df9-eddc-441a-84dd-51bc5f8dc6e4	2
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	a3b98df9-eddc-441a-84dd-51bc5f8dc6e4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-2268-01	00093226801	100 TABLET, CHEWABLE in 1 BOTTLE (0093-2268-01)	1993-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	A-S Medication Solutions	2026-08-10	HUMAN PRESCRIPTION DRUG LABEL	22
Amoxicillin	Northwind Health Company, LLC	2026-07-09	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2025-10-10	HUMAN PRESCRIPTION DRUG LABEL	24
Amoxicillin	Teva Pharmaceuticals USA, Inc.	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	35
Amoxicillin	PD-Rx Pharmaceuticals, Inc.	2025-07-17	HUMAN PRESCRIPTION DRUG LABEL	28
Amoxicillin	NuCare Pharmaceuticals, Inc.	2025-03-10	HUMAN PRESCRIPTION DRUG LABEL	6
Amoxicillin	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-06-13	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	A-S Medication Solutions	2024-04-29	HUMAN PRESCRIPTION DRUG LABEL	29
Amoxicillin	Bryant Ranch Prepack	2022-06-17	HUMAN PRESCRIPTION DRUG LABEL	100
Amoxicillin	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2022-01-25	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin	Bryant Ranch Prepack	2019-08-17	HUMAN PRESCRIPTION DRUG LABEL	3
AMOXICILLIN	DIRECT RX	2016-11-01	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Blenheim Pharmacal, Inc.	2015-07-31	HUMAN PRESCRIPTION DRUG LABEL	3